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Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment

NCT ID: NCT00162097

Last Updated: 2010-09-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-03-31

Brief Summary

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The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.

Detailed Description

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Conditions

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HIV Infections Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EFV600mg Participants With Mild Hepatic Impairment

Group Type EXPERIMENTAL

efavirenz containing antiretroviral regimen

Intervention Type DRUG

Capsule or Tablet, Oral, once daily for 2 days

EFV600mg Participants With Moderate Hepatic Impairment

Group Type EXPERIMENTAL

efavirenz containing antiretroviral regimen

Intervention Type DRUG

Capsule or Tablet, Oral, once daily for 2 days

EFV600mg Participants With Severe Hepatic Impairment

Group Type EXPERIMENTAL

efavirenz containing antiretroviral regimen

Intervention Type DRUG

Capsule or Tablet, Oral, once daily for 2 days

EFV600mg Participants With Normal Hepatic Function

Group Type ACTIVE_COMPARATOR

efavirenz containing antiretroviral regimen

Intervention Type DRUG

Capsule or Tablet, Oral, once daily for 2 days

Interventions

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efavirenz containing antiretroviral regimen

Capsule or Tablet, Oral, once daily for 2 days

Intervention Type DRUG

efavirenz containing antiretroviral regimen

Capsule or Tablet, Oral, once daily for 2 days

Intervention Type DRUG

efavirenz containing antiretroviral regimen

Capsule or Tablet, Oral, once daily for 2 days

Intervention Type DRUG

efavirenz containing antiretroviral regimen

Capsule or Tablet, Oral, once daily for 2 days

Intervention Type DRUG

Other Intervention Names

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Sustiva BMS-561525 Sustiva BMS-561525 Sustiva BMS-561525 Sustiva BMS-561525

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infection with or without Hepatitis B or C infection
* Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month
* Mild, moderate or severe hepatic impairment with hepatic cirrhosis

Exclusion Criteria

* Acute flare of hepatitis
* Positive pregnancy test for a female
* Significant acute medical illness in past 2 months
* Use of agents known to significantly affect liver metabolism
* Change in medications to treat a chronic disease in the past 2 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Johns Hopkins University School Of Medicine

Baltimore, Maryland, United States

Site Status

Uthscsa

San Antonio, Texas, United States

Site Status

Virginia Commonwealth University Health Systems

Richmond, Virginia, United States

Site Status

Local Institution

Milan, , Italy

Site Status

Countries

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United States Italy

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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AI266-917

Identifier Type: -

Identifier Source: org_study_id